NCT00124735

Brief Summary

The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to \<28 days old), infants (28 days to \<=3 months) and toddlers (\>3 months to \<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\>11 years to less than or equal to 17 years of age).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 15, 2009

Completed
Last Updated

August 24, 2016

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

July 26, 2005

Results QC Date

December 5, 2008

Last Update Submit

July 14, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Total Dose of Zemuron (Rocuronium) Administered

    Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four \[TOF\] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol \[PP\] data set)

    during surgery

Secondary Outcomes (3)

  • Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%

    after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)

  • Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%

    after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)

  • Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%

    after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)

Study Arms (2)

Rocuronium bolus maintenance

EXPERIMENTAL

Rocuronium bolus maintenance

Drug: Rocuronium bolus maintenance

Rocuronium continuous infusion maintenance

EXPERIMENTAL

Rocuronium continuous infusion maintenance

Drug: rocuronium continuous infusion maintenance

Interventions

Rocuronium bolus maintenanceDRUG

Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation

Also known as: Zemuron, ORG 9426
Rocuronium bolus maintenance
rocuronium continuous infusion maintenanceDRUG

Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation

Also known as: Zemuron, ORG 9426
Rocuronium continuous infusion maintenance

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female subjects from birth up to 17 years of age who are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).

You may not qualify if:

  • Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trials will not be allowed to enter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841.

    RESULT

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

October 1, 2004

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

August 24, 2016

Results First Posted

April 15, 2009

Record last verified: 2016-06